Alembic Pharma gets USFDA final approval for Methotrexate Injection USP

Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methotrexate Injection USP. The approval covers both 50 mg/2 mL (25 mg/mL) Multi-Dose Vials and 1g/40 mL (25 mg/mL) Single-Dose Vials. This approved ANDA is therapeutically equivalent to the reference listed drug product from Hospira, Inc. Methotrexate Injection is indicated for various neoplastic diseases, including acute lymphoblastic leukemia, non-Hodgkin lymphoma, osteosarcoma, breast cancer, and gestational trophoblastic neoplasia. It is also used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis. This approval brings Alembic's total USFDA ANDA approvals to 236, comprising 218 final and 18 tentative approvals.